3D Ultrasound Support for Hemodialysis Cannulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm feasibility study conducted at multiple centers to see if EchoMap-assisted cannulation is safe and effective when used with standard cannulation methods for patients with autologous upper-extremity AV fistulas. The study uses a two-stage design to evaluate feasibility in real-world dialysis settings. Participants are adults with a mature fistula cleared for at least one cannulation and with a history of miscannulation or a need for an expert cannulator. Interventions include EchoMap-assisted cannulation along with the standard of care, under appropriate monitoring. Result data will inform whether EchoMap merits broader testing in future research.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \> 18 years but \< 85 years of age at the time of informed consent
* Subjects who have received an upper extremity autologous arteriovenous fistula, which has been cleared for at least 1-needle cannulation
* Subjects have a fistula with a history of miscannulation or requires an expert cannulator or have a new fistula that has not previously been cannulated
* Subject is able to sign informed consent and able to participate in all testing associated with this clinical investigation

Exclusion Criteria:

* Age \<18 years old
* Subject unable to sign informed consent.
* Subject is breastfeeding, pregnant, or plans to become pregnant
* Prisoner or Subject from vulnerable populations as defined in 45 CFR 46.
* Subjects that do not have a clinically mature upper extremity AV fistula that is cleared for at least 1-needle cannulation
* Subjects that do not have a fistula with a history of miscannulation or requires an expert cannulator or do not have a new fistula that has not previously been cannulated
* Subjects that are cannulated through a buttonhole technique
* Subjects with a history of poor compliance with the dialysis protocol
* Subjects who have suffered an access related injury or underwent access related intervention in the last 2 weeks

Where it's running

• Hartford Dialysis
  Hartford, Connecticut, United States Recruiting
• Greater Waterbury Dialysis
  Middlebury, Connecticut, United States Recruiting
• CN Clinical Research
  Greenville, South Carolina, United States Recruiting

Study contacts

• Study coordinator: R Del Negro
• Email: rdelnegro@sonavex.com
• Phone: 4438622024

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.